Real-World Evidence Senior Scientist

At first glance, you’ll see that for more than 80 years we’ve been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We’re building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you’ll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful.

Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges. 

The Real-World Evidence Senior Scientist for Beckman Coulter Diagnostics is responsible to lead the design and execution of industry leading Real-World Evidence (RWE) data solutions. This individual will work closely with the cross functional partners across the Beckman Coulter organization to drive, transform and to optimize our global pre and post market clinical strategies through innovative RWE data design and collection that will drive significant impact to the organization.

This position is part of Beckman Coulter Clinical Hematology, Urinalysis, Life Sciences located in Miami, FL and will be on-site in either Chaska, MN or Miami, FL. At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time.

You will be a part of the Hematology, Urinalysis, Life Sciences and Clinical Decision Support Clinical Affairs Department and report to the Director of Clinical Affairs responsible for managing and leading the Hematology, Urinalysis, Life Sciences Clinical Affairs department. If you thrive in a multifunctional, fast paced role and want to work to build a world-class clinical affairs organization—read on.

In this role, you will have the opportunity to:

• Provide deep technical expertise for the design and delivery of studies using real-world evidence (data) to drive competitiveness of our portfolio. Ensure scientifically rigorous methods are applied for addressing medical, scientific, economic and outcomes research questions
• Generate key RWE-based insights on our early pipeline assets to drive global commercial strategies and create a competitive advantage by making better business decisions derived through strategic and patient-centric RWE approaches
• Effectively navigate technology, analytical, legal and privacy complexities to achieve objectives, and machine learning. 
• Write study protocols, data specifications, and study reports, as needed, use a variety of analytical techniques applied to various databases, and strategize regarding research programs - this also includes Clinical study data management and design, data analysis/reporting.  Leverage epidemiology methods to address emerging safety signals and queries.
• Design RWE studies to support new product development, product claims expansion, recertification of legacy products (particularly European Union Medical Device Regulation (EU-MDR)), as well as evidence which could support the reimbursement strategy.

The essential requirements of the job include:

• Bachelor’s degree in Epidemiology, Health Services Research, Health Outcomes Research, Biostatistics, Biomedical Engineering or other related field with at least 5 years of Epidemiology or related research work experience in health care is required, or Master’s degree with 3+ years, or a PhD with 0-2 years of experience.
• You will have deep knowledge and experience using a statistical programming language (e.g. SAS, R, SQL, STATA) to lead the design & development of protocols using real world data.
• Experience writing epidemiology protocols and study reports is required.
• Experience analyzing and interpreting quantitative data is required.

It would be a plus if you also possess previous experience in:

• Experience communicating complex statistical/machine learning results to technical and non-technical and their real-world advantages and drawbacks through journal publications, conferences, presentations/posters, and seminars
• Experience working in multiple therapeutic areas - experience in Oncology, Hematology, Immunology, Infectious Disease, Vaccine, Cardiovascular, Metabolic, Pulmonary Hypertension, and/or Neuroscience disease area(s) highly preferred.
• Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for real-world evidence studies or clinical trials (e.g., ISO, MDD/MDR, CFR), and prior experience in FDA and/or global regulatory submissions.

The salary range for this role is $90,000-$13